Trial Outcomes & Findings for Cancer Vaccine Targeting Brachyury Protein in Tumors (NCT NCT01519817)
NCT ID: NCT01519817
Last Updated: 2018-01-29
Results Overview
A fluorescense activated cell sorting (FACS)-based assay for cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) T-cells expressing the cytokines interferon (IFN) gamma, interleukin 2 (IL2), and tumor necrosis factor (TNF) alpha, and/or cluster of differentiation 107a (CD107a) (a marker for lytic potential) was used to determine the numbers of participants showing development or enhancement of the level of brachyury-specific T-cells after vaccination.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Baseline (pre-vaccination) and approximately day 84 (after 6 vaccinations)
Results posted on
2018-01-29
Participant Flow
Participant milestones
| Measure |
80 YU (Dose Level 4)
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
4 YU (Dose Level 1)
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
16 YU (Dose Level 2)
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
40 YU (Dose Level 3)
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
4
|
3
|
16
|
|
Overall Study
COMPLETED
|
10
|
3
|
3
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
80 YU (Dose Level 4)
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
4 YU (Dose Level 1)
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
16 YU (Dose Level 2)
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
40 YU (Dose Level 3)
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Off study due to infection
|
1
|
0
|
0
|
0
|
Baseline Characteristics
23 participants with carcinomas (solid tumors) and 11 participants with chordomas.
Baseline characteristics by cohort
| Measure |
All Participants
n=34 Participants
All participants who received at least one dose of 4YU, 16YU, 40YU or 80YU.
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
GI-6301 (Yeast Brachyury Vaccine): GI-6301 is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=34 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=34 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=34 Participants
|
|
Age, Continuous
|
58 years
n=34 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=34 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=34 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=34 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=34 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=34 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
33 Participants
n=34 Participants
|
|
Race/Ethnicity, Customized
Mexican, Puerto Rican, Cuban Central or So. Americ
|
1 Participants
n=34 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=34 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
14 Participants
n=34 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
20 Participants
n=34 Participants
|
|
Tumor Type
Colorectal
|
11 Participants
n=34 Participants
|
|
Tumor Type
Chordoma
|
11 Participants
n=34 Participants
|
|
Tumor Type
Breast
|
5 Participants
n=34 Participants
|
|
Tumor Type
Pancreatic
|
3 Participants
n=34 Participants
|
|
Tumor Type
Prostate
|
2 Participants
n=34 Participants
|
|
Tumor Type
Urothelial
|
1 Participants
n=34 Participants
|
|
Tumor Type
Lung
|
1 Participants
n=34 Participants
|
|
Disease at Study Entry
Carcinomas · Stable disease
|
1 Participants
n=23 Participants • 23 participants with carcinomas (solid tumors) and 11 participants with chordomas.
|
|
Disease at Study Entry
Carcinomas · Progressive disease
|
22 Participants
n=23 Participants • 23 participants with carcinomas (solid tumors) and 11 participants with chordomas.
|
|
Disease at Study Entry
Chordomas · Stable disease
|
2 Participants
n=11 Participants • 23 participants with carcinomas (solid tumors) and 11 participants with chordomas.
|
|
Disease at Study Entry
Chordomas · Progressive disease
|
9 Participants
n=11 Participants • 23 participants with carcinomas (solid tumors) and 11 participants with chordomas.
|
|
Prior Cytotoxic Regimens
0
|
1 Participants
n=23 Participants • The module refers to 23 participants with carcinomas (solid tumors).
|
|
Prior Cytotoxic Regimens
1 regimen
|
2 Participants
n=23 Participants • The module refers to 23 participants with carcinomas (solid tumors).
|
|
Prior Cytotoxic Regimens
2 regimens
|
8 Participants
n=23 Participants • The module refers to 23 participants with carcinomas (solid tumors).
|
|
Prior Cytotoxic Regimens
≥3 regimens
|
12 Participants
n=23 Participants • The module refers to 23 participants with carcinomas (solid tumors).
|
|
Tumor Anatomical Location
Sacral
|
6 Participants
n=11 Participants • The module refers to 11 participants with chordomas.
|
|
Tumor Anatomical Location
Clival
|
3 Participants
n=11 Participants • The module refers to 11 participants with chordomas.
|
|
Tumor Anatomical Location
Spinal
|
2 Participants
n=11 Participants • The module refers to 11 participants with chordomas.
|
|
Prior Therapy
Surgery
|
11 Participants
n=11 Participants • The module refers to 11 participants with chordomas.
|
|
Prior Therapy
Radiotherapy
|
11 Participants
n=11 Participants • The module refers to 11 participants with chordomas.
|
|
Prior Therapy
Systemic therapy
|
5 Participants
n=11 Participants • The module refers to 11 participants with chordomas.
|
PRIMARY outcome
Timeframe: Baseline (pre-vaccination) and approximately day 84 (after 6 vaccinations)Population: Sufficient peripheral blood mononuclear cells (PBMCs) were available before and after vaccination from 31 of 34 patients to analyze brachyury-specific CD4 and CD8 T-cell responses.
A fluorescense activated cell sorting (FACS)-based assay for cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) T-cells expressing the cytokines interferon (IFN) gamma, interleukin 2 (IL2), and tumor necrosis factor (TNF) alpha, and/or cluster of differentiation 107a (CD107a) (a marker for lytic potential) was used to determine the numbers of participants showing development or enhancement of the level of brachyury-specific T-cells after vaccination.
Outcome measures
| Measure |
4 YU (Dose Level 1)
n=3 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
16 YU (Dose Level 2)
n=3 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
40 YU (Dose Level 3)
n=16 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
80 YU (Dose Level 4)
n=9 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
|---|---|---|---|---|
|
Number of Participants With Brachyury-Specific T-cell Responses
CD107a + CD4 T-cell response
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Brachyury-Specific T-cell Responses
IFN gamma + CD4 T-cell response
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Brachyury-Specific T-cell Responses
IL2 + CD4 T-cell response
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Brachyury-Specific T-cell Responses
TNF alpha + CD4 T-cell response
|
0 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Brachyury-Specific T-cell Responses
CD107a + CD8 T-cell response
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Brachyury-Specific T-cell Responses
IFN gamma + CD8 T-cell response
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Brachyury-Specific T-cell Responses
IL2 + CD8 T-cell response
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Brachyury-Specific T-cell Responses
TNF alpha + CD8 T-cell response
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Brachyury-Specific T-cell Responses
Any T-cell response
|
1 Participants
|
1 Participants
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 4 years and 25 daysHere is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. A non-serious adverse event is any untoward medical occurrence.
Outcome measures
| Measure |
4 YU (Dose Level 1)
n=4 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
16 YU (Dose Level 2)
n=3 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
40 YU (Dose Level 3)
n=16 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
80 YU (Dose Level 4)
n=11 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
|---|---|---|---|---|
|
Count of Participants With Adverse Events of Escalating Doses of Yeast Brachyury ( GI- 6301) Vaccine
|
4 Participants
|
3 Participants
|
16 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 3 and 5 months restagingPopulation: One participant was not evaluable and came off study due to infection prior to restaging. Two participants were not evaluable due to withdrawal from the study or lack of measurable disease. Three patients with stable disease at 3 months elected to pursue alternate treatment and did not have 5 month restaging.
Clinical benefit is defined as partial response (PR) or stable disease (SD) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Partial response is ≥30% decrease in the sum of greatest diameters/no new lesions. Progressive disease is ≥20% increase in the sum of greatest diameters/new lesions. Stable disease does not meet criteria for complete response (disappearance of all lesions; no new lesions), partial response, or progressive disease.
Outcome measures
| Measure |
4 YU (Dose Level 1)
n=4 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
16 YU (Dose Level 2)
n=3 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
40 YU (Dose Level 3)
n=16 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
80 YU (Dose Level 4)
n=11 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
|---|---|---|---|---|
|
Number of Participants With a Clinical Benefit Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)
Stable disease at 3 months
|
3 Participants
|
0 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With a Clinical Benefit Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)
Stable disease at 5 months
|
2 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With a Clinical Benefit Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)
Partial response at 3 months
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Clinical Benefit Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)
Partial response at 5 months
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Clinical Benefit Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive disease at 3 months
|
1 Participants
|
3 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With a Clinical Benefit Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive disease at 5 months
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre (Baseline) and Day 85 after 6 vaccinationsPopulation: Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.
Blood samples will be collected via apheresis and analyzed by multicolor flow cytometry in PBMCs for cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), Natural Killer (NK), Natural Killer T (NKT), conventional dendritic cell (cDC), plasmacytoid dendritic cell (pDC), myeloid-derived suppressor cell (MDSC), Tregs, CD4 central memory (CD4 CM), CD4 effector memory (CD4 EM), CD4 terminal effector memory (CD4 EMRA), CD4 naïve, CD8 CM, CD8 EM, CD8 EMRA, and CD8 naïve cells. Significance of changes in immune cells was determined by p value (Wilcoxon test) and the median and interquartile range of data.
Outcome measures
| Measure |
4 YU (Dose Level 1)
n=4 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
16 YU (Dose Level 2)
n=2 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
40 YU (Dose Level 3)
n=13 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
80 YU (Dose Level 4)
n=9 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
|---|---|---|---|---|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD4 Pre
|
37.70 percentage of PBMC
Interval 24.11 to 46.36
|
43.57 percentage of PBMC
Interval 40.26 to 46.87
|
29.30 percentage of PBMC
Interval 24.65 to 39.77
|
33.58 percentage of PBMC
Interval 26.84 to 39.92
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD4 d85
|
38.61 percentage of PBMC
Interval 24.44 to 47.73
|
33.44 percentage of PBMC
Interval 33.37 to 33.52
|
34.29 percentage of PBMC
Interval 25.56 to 37.44
|
27.99 percentage of PBMC
Interval 25.85 to 39.38
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD8 Pre
|
15.87 percentage of PBMC
Interval 8.26 to 16.86
|
14.77 percentage of PBMC
Interval 3.49 to 26.04
|
15.96 percentage of PBMC
Interval 10.76 to 19.48
|
13.76 percentage of PBMC
Interval 10.31 to 19.77
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD8 d85
|
15.67 percentage of PBMC
Interval 9.102 to 16.57
|
13.63 percentage of PBMC
Interval 4.123 to 23.14
|
15.42 percentage of PBMC
Interval 10.96 to 22.44
|
16.02 percentage of PBMC
Interval 10.57 to 25.5
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median B cells Pre
|
7.05 percentage of PBMC
Interval 6.19 to 10.07
|
11.02 percentage of PBMC
Interval 9.92 to 12.11
|
8.97 percentage of PBMC
Interval 3.54 to 12.13
|
7.82 percentage of PBMC
Interval 3.13 to 12.07
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median B cells d85
|
6.93 percentage of PBMC
Interval 6.16 to 10.58
|
9.78 percentage of PBMC
Interval 7.95 to 11.62
|
9.10 percentage of PBMC
Interval 5.07 to 12.17
|
8.77 percentage of PBMC
Interval 3.78 to 10.72
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median Natural Killer (NK) Pre
|
5.21 percentage of PBMC
Interval 4.14 to 6.94
|
6.57 percentage of PBMC
Interval 3.27 to 9.87
|
5.72 percentage of PBMC
Interval 3.13 to 8.51
|
5.89 percentage of PBMC
Interval 4.59 to 9.14
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median Natural Killer (NK) d85
|
5.72 percentage of PBMC
Interval 4.03 to 7.39
|
8.41 percentage of PBMC
Interval 5.5 to 11.31
|
4.22 percentage of PBMC
Interval 3.97 to 10.07
|
9.14 percentage of PBMC
Interval 5.95 to 11.4
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median Natural Killer T cell (NKT) Pre
|
1.00 percentage of PBMC
Interval 0.65 to 4.21
|
1.70 percentage of PBMC
Interval 0.46 to 2.94
|
1.27 percentage of PBMC
Interval 0.62 to 2.81
|
2.24 percentage of PBMC
Interval 0.59 to 4.39
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median Natural Killer T cell (NKT) d85
|
1.25 percentage of PBMC
Interval 0.67 to 4.75
|
2.46 percentage of PBMC
Interval 0.51 to 4.4
|
1.19 percentage of PBMC
Interval 0.58 to 3.15
|
2.53 percentage of PBMC
Interval 0.77 to 5.86
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median cDC Pre
|
0.25 percentage of PBMC
Interval 0.14 to 0.28
|
0.14 percentage of PBMC
Interval 0.11 to 0.17
|
0.23 percentage of PBMC
Interval 0.2 to 0.37
|
0.17 percentage of PBMC
Interval 0.16 to 0.35
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median cDC d85
|
0.18 percentage of PBMC
Interval 0.14 to 0.23
|
0.17 percentage of PBMC
Interval 0.16 to 0.19
|
0.21 percentage of PBMC
Interval 0.18 to 0.34
|
0.19 percentage of PBMC
Interval 0.09 to 0.23
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median pDC Pre
|
0.25 percentage of PBMC
Interval 0.2 to 0.37
|
0.17 percentage of PBMC
Interval 0.09 to 0.24
|
0.23 percentage of PBMC
Interval 0.17 to 0.36
|
0.23 percentage of PBMC
Interval 0.11 to 0.31
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median pDC d85
|
0.32 percentage of PBMC
Interval 0.27 to 0.38
|
0.26 percentage of PBMC
Interval 0.08 to 0.44
|
0.27 percentage of PBMC
Interval 0.18 to 0.35
|
0.23 percentage of PBMC
Interval 0.14 to 0.4
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median MDSC Pre
|
10.98 percentage of PBMC
Interval 2.96 to 19.19
|
8.53 percentage of PBMC
Interval 4.3 to 12.76
|
8.47 percentage of PBMC
Interval 5.98 to 14.54
|
13.73 percentage of PBMC
Interval 5.41 to 17.61
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median MDSC d85
|
11.41 percentage of PBMC
Interval 4.82 to 18.78
|
10.78 percentage of PBMC
Interval 5.98 to 15.58
|
7.55 percentage of PBMC
Interval 4.95 to 12.16
|
12.77 percentage of PBMC
Interval 6.64 to 14.23
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median Treg Pre
|
0.77 percentage of PBMC
Interval 0.66 to 0.9
|
0.90 percentage of PBMC
Interval 0.68 to 1.13
|
1.25 percentage of PBMC
Interval 0.73 to 1.74
|
1.07 percentage of PBMC
Interval 0.55 to 1.6
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median Treg d85
|
0.81 percentage of PBMC
Interval 0.78 to 1.03
|
0.80 percentage of PBMC
Interval 0.42 to 1.17
|
1.12 percentage of PBMC
Interval 0.83 to 1.71
|
1.00 percentage of PBMC
Interval 0.45 to 1.41
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD4 EM Pre
|
10.58 percentage of PBMC
Interval 8.47 to 12.73
|
12.09 percentage of PBMC
Interval 9.67 to 14.51
|
13.14 percentage of PBMC
Interval 10.67 to 14.82
|
11.31 percentage of PBMC
Interval 8.49 to 15.97
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD4 EM d85
|
8.92 percentage of PBMC
Interval 7.49 to 13.48
|
10.72 percentage of PBMC
Interval 9.2 to 12.25
|
12.50 percentage of PBMC
Interval 11.33 to 13.63
|
9.76 percentage of PBMC
Interval 7.21 to 15.68
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD4 CM Pre
|
17.29 percentage of PBMC
Interval 8.59 to 21.1
|
23.20 percentage of PBMC
Interval 12.62 to 33.79
|
12.36 percentage of PBMC
Interval 9.16 to 17.44
|
12.07 percentage of PBMC
Interval 7.52 to 16.56
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD4 CM d85
|
18.80 percentage of PBMC
Interval 9.75 to 24.37
|
16.51 percentage of PBMC
Interval 10.97 to 22.06
|
12.78 percentage of PBMC
Interval 10.53 to 17.98
|
11.36 percentage of PBMC
Interval 6.0 to 14.4
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD4 EMRA Pre
|
0.32 percentage of PBMC
Interval 0.28 to 1.96
|
0.68 percentage of PBMC
Interval 0.21 to 1.15
|
0.34 percentage of PBMC
Interval 0.26 to 0.9
|
0.28 percentage of PBMC
Interval 0.21 to 1.04
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD4 EMRA d85
|
0.34 percentage of PBMC
Interval 0.26 to 0.7
|
0.83 percentage of PBMC
Interval 0.24 to 1.43
|
0.28 percentage of PBMC
Interval 0.23 to 0.56
|
0.38 percentage of PBMC
Interval 0.21 to 1.75
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD4 naive Pre
|
10.28 percentage of PBMC
Interval 4.23 to 12.36
|
7.57 percentage of PBMC
Interval 3.23 to 11.91
|
3.78 percentage of PBMC
Interval 2.47 to 6.9
|
4.49 percentage of PBMC
Interval 2.56 to 10.22
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD4 naive d85
|
8.48 percentage of PBMC
Interval 4.14 to 12.76
|
5.41 percentage of PBMC
Interval 2.08 to 8.73
|
3.99 percentage of PBMC
Interval 3.49 to 7.51
|
6.08 percentage of PBMC
Interval 3.15 to 9.55
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD8 EM Pre
|
3.20 percentage of PBMC
Interval 2.33 to 6.85
|
2.70 percentage of PBMC
Interval 1.54 to 3.86
|
7.19 percentage of PBMC
Interval 4.45 to 8.92
|
5.23 percentage of PBMC
Interval 4.21 to 7.64
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD8 EM d85
|
3.44 percentage of PBMC
Interval 2.85 to 6.87
|
3.33 percentage of PBMC
Interval 2.61 to 4.06
|
6.60 percentage of PBMC
Interval 4.12 to 10.78
|
6.11 percentage of PBMC
Interval 3.91 to 7.3
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD8 CM Pre
|
1.03 percentage of PBMC
Interval 0.61 to 2.7
|
1.05 percentage of PBMC
Interval 0.8 to 1.3
|
1.16 percentage of PBMC
Interval 0.56 to 1.48
|
1.00 percentage of PBMC
Interval 0.53 to 1.38
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD8 CM d85
|
1.31 percentage of PBMC
Interval 0.81 to 2.43
|
0.86 percentage of PBMC
Interval 0.53 to 1.19
|
0.95 percentage of PBMC
Interval 0.8 to 1.44
|
0.88 percentage of PBMC
Interval 0.32 to 1.26
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD8 EMRA Pre
|
3.01 percentage of PBMC
Interval 1.22 to 8.46
|
2.51 percentage of PBMC
Interval 0.63 to 4.39
|
2.60 percentage of PBMC
Interval 1.36 to 9.95
|
5.81 percentage of PBMC
Interval 2.26 to 8.75
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD8 EMRA d85
|
2.84 percentage of PBMC
Interval 1.4 to 7.35
|
3.24 percentage of PBMC
Interval 0.69 to 5.8
|
3.31 percentage of PBMC
Interval 1.14 to 10.71
|
5.06 percentage of PBMC
Interval 3.11 to 10.83
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD8 naive Pre
|
3.47 percentage of PBMC
Interval 2.5 to 5.6
|
8.51 percentage of PBMC
Interval 0.53 to 16.49
|
2.43 percentage of PBMC
Interval 0.92 to 5.25
|
3.71 percentage of PBMC
Interval 2.86 to 5.92
|
|
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Median CD8 naive d85
|
3.28 percentage of PBMC
Interval 2.58 to 6.21
|
6.20 percentage of PBMC
Interval 0.3 to 12.09
|
3.12 percentage of PBMC
Interval 1.0 to 5.82
|
3.44 percentage of PBMC
Interval 2.06 to 5.45
|
SECONDARY outcome
Timeframe: Pre (Baseline) and Day 85 after 6 vaccinationsPopulation: Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.
Blood samples were collected and changes in serum levels of cytokines interferon gamma (IFNg), Interleukin 10 (IL-10), Interleukin 12 (IL-12)p70, Interleukin 1b (IL-1b), Interleukin 2 (IL-2), Interleukin 6 (IL-6), Interleukin 8 (IL-8), and tumor necrosis factor (TNF) were assessed by the multiplexed mesoscale assay. Significance of changes in serum levels of cytokines was determined by p value (Wilcoxon test) and the median and interquartile range of data.
Outcome measures
| Measure |
4 YU (Dose Level 1)
n=4 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
16 YU (Dose Level 2)
n=2 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
40 YU (Dose Level 3)
n=12 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
80 YU (Dose Level 4)
n=9 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
|---|---|---|---|---|
|
Changes in Serum Levels of Cytokines
Median IFNg Pre
|
3.63 pg/ml
Interval 2.47 to 6.12
|
3.56 pg/ml
Interval 2.99 to 4.13
|
2.805 pg/ml
Interval 1.97 to 3.6
|
4.47 pg/ml
Interval 4.05 to 7.48
|
|
Changes in Serum Levels of Cytokines
Median IFNg d85
|
2.64 pg/ml
Interval 2.17 to 3.17
|
2.83 pg/ml
Interval 2.62 to 3.04
|
2.84 pg/ml
Interval 1.76 to 4.71
|
4.9 pg/ml
Interval 2.91 to 6.81
|
|
Changes in Serum Levels of Cytokines
Median IL-10 Pre
|
0.24 pg/ml
Interval 0.17 to 0.54
|
0.215 pg/ml
Interval 0.2 to 0.23
|
0.21 pg/ml
Interval 0.17 to 0.28
|
0.4 pg/ml
Interval 0.31 to 0.47
|
|
Changes in Serum Levels of Cytokines
Median IL-10 d85
|
0.26 pg/ml
Interval 0.23 to 0.39
|
0.285 pg/ml
Interval 0.28 to 0.29
|
0.24 pg/ml
Interval 0.18 to 0.31
|
0.4 pg/ml
Interval 0.26 to 0.52
|
|
Changes in Serum Levels of Cytokines
Median IL-12p70 Pre
|
0.2 pg/ml
Interval 0.2 to 0.22
|
0.22 pg/ml
Interval 0.2 to 0.24
|
0.2 pg/ml
Interval 0.2 to 0.2
|
0.2 pg/ml
Interval 0.2 to 0.37
|
|
Changes in Serum Levels of Cytokines
Median IL-12p70 d85
|
0.2 pg/ml
Interval 0.2 to 0.28
|
0.2 pg/ml
Interval 0.2 to 0.2
|
0.2 pg/ml
Interval 0.2 to 0.2
|
0.2 pg/ml
Interval 0.2 to 0.26
|
|
Changes in Serum Levels of Cytokines
Median IL-1b Pre
|
0.24 pg/ml
Interval 0.24 to 1.15
|
0.24 pg/ml
Interval 0.24 to 0.24
|
0.24 pg/ml
Interval 0.24 to 0.24
|
0.24 pg/ml
Interval 0.24 to 2.52
|
|
Changes in Serum Levels of Cytokines
Median IL-1b d85
|
0.24 pg/ml
Interval 0.24 to 0.25
|
0.24 pg/ml
Interval 0.24 to 0.24
|
0.24 pg/ml
Interval 0.24 to 0.24
|
0.24 pg/ml
Interval 0.24 to 0.89
|
|
Changes in Serum Levels of Cytokines
Median IL-2 Pre
|
0.64 pg/ml
Interval 0.64 to 2.4
|
0.64 pg/ml
Interval 0.64 to 0.64
|
0.64 pg/ml
Interval 0.64 to 0.64
|
0.64 pg/ml
Interval 0.64 to 0.8
|
|
Changes in Serum Levels of Cytokines
Median IL-2 d85
|
0.64 pg/ml
Interval 0.64 to 0.93
|
0.64 pg/ml
Interval 0.64 to 0.64
|
0.64 pg/ml
Interval 0.64 to 0.64
|
0.64 pg/ml
Interval 0.64 to 0.7
|
|
Changes in Serum Levels of Cytokines
Median IL-6 Pre
|
0.88 pg/ml
Interval 0.71 to 2.85
|
0.78 pg/ml
Interval 0.66 to 0.9
|
1.02 pg/ml
Interval 0.52 to 1.3
|
2.37 pg/ml
Interval 0.69 to 15.3
|
|
Changes in Serum Levels of Cytokines
Median IL-6 d85
|
0.97 pg/ml
Interval 0.74 to 1.23
|
0.855 pg/ml
Interval 0.76 to 0.95
|
1.04 pg/ml
Interval 0.54 to 1.97
|
2.84 pg/ml
Interval 0.9 to 4.84
|
|
Changes in Serum Levels of Cytokines
Median IL-8 Pre
|
56.45 pg/ml
Interval 16.84 to 487.6
|
43.87 pg/ml
Interval 16.05 to 71.69
|
37.49 pg/ml
Interval 18.0 to 91.01
|
63.52 pg/ml
Interval 33.7 to 560.2
|
|
Changes in Serum Levels of Cytokines
Median IL-8 d85
|
33.29 pg/ml
Interval 30.52 to 124.5
|
61.85 pg/ml
Interval 44.98 to 78.71
|
43.27 pg/ml
Interval 17.99 to 140.1
|
73.21 pg/ml
Interval 38.62 to 200.9
|
|
Changes in Serum Levels of Cytokines
Median TNF Pre
|
1.54 pg/ml
Interval 1.19 to 8.19
|
1.315 pg/ml
Interval 1.24 to 1.39
|
1.62 pg/ml
Interval 1.25 to 2.26
|
3.59 pg/ml
Interval 2.19 to 9.24
|
|
Changes in Serum Levels of Cytokines
Median TNF d85
|
1.63 pg/ml
Interval 1.45 to 1.81
|
1.465 pg/ml
Interval 1.23 to 1.7
|
1.67 pg/ml
Interval 1.38 to 2.07
|
2.74 pg/ml
Interval 2.26 to 3.77
|
SECONDARY outcome
Timeframe: Pre (Baseline) and Day 85 after 6 vaccinationsPopulation: Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.
Blood samples were collected and changes in serum levels of soluble sCD27 were assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD27 was determined by p value (Wilcoxon test) and the median and interquartile range of data.
Outcome measures
| Measure |
4 YU (Dose Level 1)
n=4 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
16 YU (Dose Level 2)
n=2 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
40 YU (Dose Level 3)
n=12 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
80 YU (Dose Level 4)
n=9 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
|---|---|---|---|---|
|
Changes in Soluble Cluster of Differentiation 27 (sCD27)
Median sCD27 Pre
|
99.07 U/ml
Interval 91.13 to 131.0
|
98.63 U/ml
Interval 87.12 to 110.1
|
97.47 U/ml
Interval 85.15 to 110.9
|
128.4 U/ml
Interval 123.9 to 145.6
|
|
Changes in Soluble Cluster of Differentiation 27 (sCD27)
Median sCD27 d85
|
97.17 U/ml
Interval 92.07 to 1112.0
|
92.07 U/ml
Interval 83.3 to 100.8
|
101.7 U/ml
Interval 98.85 to 105.1
|
133.1 U/ml
Interval 129.7 to 155.8
|
SECONDARY outcome
Timeframe: Pre (Baseline) and Day 85 after 6 vaccinationsPopulation: Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.
Blood samples were collected and changes in serum levels of the ratio of soluble sCD27:sCD40L was assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD27:sCD40L was determined by p value (Wilcoxon test) and the median and interquartile range of data.
Outcome measures
| Measure |
4 YU (Dose Level 1)
n=4 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
16 YU (Dose Level 2)
n=2 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
40 YU (Dose Level 3)
n=12 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
80 YU (Dose Level 4)
n=9 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
|---|---|---|---|---|
|
Median Ratio of Soluble Cluster of Differentiation 27:40L (sCD27:sCD40L)
Median sCD27:sCD40L Pre
|
5.982 Ratio
Interval 5.71 to 11.67
|
9.57 Ratio
Interval 7.88 to 11.26
|
9.571 Ratio
Interval 7.67 to 19.89
|
8.57 Ratio
Interval 6.93 to 10.62
|
|
Median Ratio of Soluble Cluster of Differentiation 27:40L (sCD27:sCD40L)
Median sCD27:sCD40L d85
|
6.428 Ratio
Interval 4.79 to 9.43
|
8.294 Ratio
Interval 7.29 to 9.29
|
10.47 Ratio
Interval 6.63 to 19.38
|
8.257 Ratio
Interval 6.96 to 8.91
|
SECONDARY outcome
Timeframe: Pre (Baseline) and Day 85 after 6 vaccinationsPopulation: Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.
Blood samples were collected and changes in serum levels of soluble sCD27 were assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD40L was determined by p value (Wilcoxon test) and the median and interquartile range of data.
Outcome measures
| Measure |
4 YU (Dose Level 1)
n=4 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
16 YU (Dose Level 2)
n=2 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
40 YU (Dose Level 3)
n=12 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
80 YU (Dose Level 4)
n=9 Participants
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
|---|---|---|---|---|
|
Changes in Soluble Cluster of Differentiation 40L (sCD40L)
Median sCD40L Pre
|
15.3 ng/ml
Interval 11.39 to 17.99
|
10.24 ng/ml
Interval 9.78 to 11.06
|
9.648 ng/ml
Interval 5.27 to 13.99
|
14.72 ng/ml
Interval 13.67 to 18.74
|
|
Changes in Soluble Cluster of Differentiation 40L (sCD40L)
Median sCD40L d85
|
15.23 ng/ml
Interval 11.96 to 19.42
|
11.14 ng/ml
Interval 10.84 to 11.43
|
9.854 ng/ml
Interval 5.86 to 14.52
|
18.57 ng/ml
Interval 16.09 to 19.51
|
Adverse Events
4 YU (Dose Level 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
16 YU (Dose Level 2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
40 YU (Dose Level 3)
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
80 YU (Dose Level 4)
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
4 YU (Dose Level 1)
n=4 participants at risk
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
16 YU (Dose Level 2)
n=3 participants at risk
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
40 YU (Dose Level 3)
n=16 participants at risk
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
80 YU (Dose Level 4)
n=11 participants at risk
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
18.8%
3/16 • Number of events 3 • 4 years and 25 days
|
18.2%
2/11 • Number of events 2 • 4 years and 25 days
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Infections and infestations
Bone infection
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Eye disorders
Eye infection
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
General disorders
Fatigue
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 2 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, lung obstruction
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
Other adverse events
| Measure |
4 YU (Dose Level 1)
n=4 participants at risk
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
16 YU (Dose Level 2)
n=3 participants at risk
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
40 YU (Dose Level 3)
n=16 participants at risk
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
80 YU (Dose Level 4)
n=11 participants at risk
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
|
|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
18.8%
3/16 • Number of events 4 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
1/4 • Number of events 2 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
25.0%
4/16 • Number of events 4 • 4 years and 25 days
|
27.3%
3/11 • Number of events 3 • 4 years and 25 days
|
|
Eye disorders
Conjunctivitis
|
25.0%
1/4 • Number of events 1 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Renal and urinary disorders
Cystitis noninfective
|
25.0%
1/4 • Number of events 1 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 2 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
18.2%
2/11 • Number of events 2 • 4 years and 25 days
|
|
General disorders
Edema face
|
25.0%
1/4 • Number of events 1 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
General disorders
Edema limbs
|
25.0%
1/4 • Number of events 1 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 1 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
General disorders
Flu like symptoms
|
25.0%
1/4 • Number of events 1 • 4 years and 25 days
|
33.3%
1/3 • Number of events 1 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
2/4 • Number of events 6 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
General disorders
Injection site reaction
|
100.0%
4/4 • Number of events 7 • 4 years and 25 days
|
33.3%
1/3 • Number of events 2 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
81.8%
9/11 • Number of events 33 • 4 years and 25 days
|
|
Investigations
Lymphocyte count decreased
|
75.0%
3/4 • Number of events 4 • 4 years and 25 days
|
33.3%
1/3 • Number of events 1 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
General disorders
Pain
|
50.0%
2/4 • Number of events 3 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
27.3%
3/11 • Number of events 4 • 4 years and 25 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Number of events 1 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
18.8%
3/16 • Number of events 3 • 4 years and 25 days
|
18.2%
2/11 • Number of events 2 • 4 years and 25 days
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Number of events 2 • 4 years and 25 days
|
33.3%
1/3 • Number of events 1 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
25.0%
1/4 • Number of events 1 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
25.0%
1/4 • Number of events 1 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Renal and urinary disorders
Urinary urgency
|
25.0%
1/4 • Number of events 1 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • 4 years and 25 days
|
66.7%
2/3 • Number of events 3 • 4 years and 25 days
|
68.8%
11/16 • Number of events 16 • 4 years and 25 days
|
27.3%
3/11 • Number of events 7 • 4 years and 25 days
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • 4 years and 25 days
|
33.3%
1/3 • Number of events 1 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • 4 years and 25 days
|
33.3%
1/3 • Number of events 1 • 4 years and 25 days
|
12.5%
2/16 • Number of events 2 • 4 years and 25 days
|
18.2%
2/11 • Number of events 2 • 4 years and 25 days
|
|
Eye disorders
Cataract
|
0.00%
0/4 • 4 years and 25 days
|
33.3%
1/3 • Number of events 1 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
General disorders
Fever
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
12.5%
2/16 • Number of events 3 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • 4 years and 25 days
|
33.3%
1/3 • Number of events 1 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
45.5%
5/11 • Number of events 9 • 4 years and 25 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/4 • 4 years and 25 days
|
33.3%
1/3 • Number of events 1 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/4 • 4 years and 25 days
|
33.3%
1/3 • Number of events 1 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • 4 years and 25 days
|
33.3%
1/3 • Number of events 1 • 4 years and 25 days
|
12.5%
2/16 • Number of events 2 • 4 years and 25 days
|
18.2%
2/11 • Number of events 2 • 4 years and 25 days
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • 4 years and 25 days
|
33.3%
1/3 • Number of events 2 • 4 years and 25 days
|
18.8%
3/16 • Number of events 4 • 4 years and 25 days
|
9.1%
1/11 • Number of events 3 • 4 years and 25 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other,R hand skin mass,excision 11/27/12
|
0.00%
0/4 • 4 years and 25 days
|
33.3%
1/3 • Number of events 1 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/4 • 4 years and 25 days
|
33.3%
1/3 • Number of events 1 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Investigations
Weight loss
|
0.00%
0/4 • 4 years and 25 days
|
33.3%
1/3 • Number of events 1 • 4 years and 25 days
|
6.2%
1/16 • Number of events 2 • 4 years and 25 days
|
18.2%
2/11 • Number of events 2 • 4 years and 25 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 3 • 4 years and 25 days
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Cardiac disorders
Cardiac troponin I increased
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 2 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
General disorders
Chills
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
18.8%
3/16 • Number of events 4 • 4 years and 25 days
|
27.3%
3/11 • Number of events 3 • 4 years and 25 days
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
12.5%
2/16 • Number of events 3 • 4 years and 25 days
|
27.3%
3/11 • Number of events 6 • 4 years and 25 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
General disorders
Fatigue
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
12.5%
2/16 • Number of events 3 • 4 years and 25 days
|
36.4%
4/11 • Number of events 4 • 4 years and 25 days
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 2 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
18.8%
3/16 • Number of events 3 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
18.8%
3/16 • Number of events 3 • 4 years and 25 days
|
18.2%
2/11 • Number of events 3 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
18.2%
2/11 • Number of events 2 • 4 years and 25 days
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
18.2%
2/11 • Number of events 2 • 4 years and 25 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
12.5%
2/16 • Number of events 2 • 4 years and 25 days
|
18.2%
2/11 • Number of events 2 • 4 years and 25 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
27.3%
3/11 • Number of events 3 • 4 years and 25 days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
31.2%
5/16 • Number of events 6 • 4 years and 25 days
|
9.1%
1/11 • Number of events 2 • 4 years and 25 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Infections and infestations
Infections and infestations - Other, herpes zoster
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
100.0%
4/4 • Number of events 7 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
62.5%
10/16 • Number of events 23 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, hemoglobinuria
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Nervous system disorders
Nervous system disorders - Other, lightheadedness
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 2 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
12.5%
2/16 • Number of events 2 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
18.8%
3/16 • Number of events 5 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
12.5%
2/16 • Number of events 2 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Investigations
White blood cell decreased
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
31.2%
5/16 • Number of events 5 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Infections and infestations
Eye infection
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
18.2%
2/11 • Number of events 2 • 4 years and 25 days
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, poor appetite
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Vascular disorders
Hot flashes
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Infections and infestations
Infections and infestations - Other, nephrostomy tube site
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 2 • 4 years and 25 days
|
|
Vascular disorders
Lymphedema
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 2 • 4 years and 25 days
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder-Other, R knee swelling
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Body aches
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Erythema/redness R LE
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, sebac cyst-back
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
6.2%
1/16 • Number of events 1 • 4 years and 25 days
|
0.00%
0/11 • 4 years and 25 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, R knee redness
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, bruised R big toe
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, itching nose intermittent
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, top R foot open wound
|
0.00%
0/4 • 4 years and 25 days
|
0.00%
0/3 • 4 years and 25 days
|
0.00%
0/16 • 4 years and 25 days
|
9.1%
1/11 • Number of events 1 • 4 years and 25 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place